Not for use in humans. Keep out of reach of children.
Keep Furosemide Tablets in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.
Furosemide Tablets are a highly effective diuretic and if given in excessive amounts as with any diuretic may lead to excessive diuresis which could result in electrolyte imbalance, dehydration and reduction of plasma volume enhancing the risk of circulatory collapse, thrombosis, and embolism. Therefore, the animal should be observed for early signs of fluid depletion with electrolyte imbalance, and corrective measures administered. Excessive loss of potassium in patients receiving digitalis or its glycosides may precipitate digitalis toxicity. Caution should be exercised in animals administered potassium-depleting steroids.
It is important to correct potassium deficiency with dietary supplementation. Caution should be exercised in prescribing enteric-coated potassium tablets. There have been several reports in human literature, published and unpublished, concerning nonspecific small-bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric-coated thiazides with potassium salts.
These lesions may occur with enteric-coated potassium tablets alone or when they are used with nonenteric-coated thiazides, or certain other oral diuretics. These small-bowel lesions may have caused obstruction, hemorrhage, and perforation. Surgery was frequently required, and deaths have occured. Available information tends to implicate enteric-coated potassium salts, although lesions of this type also occur spontaneously. Therefore, coated potassium-containing formulations should be administered only when indicated and should be discontinued immediately if abdominal pain, distention, nausea, vomiting, or gastro-intestinal bleeding occurs.
Human patients with known sulfonamide sensitivity may show allergic reactions to Furosemide Tablets; however, these reactions have not been reported in animals.
Sulfonamide diuretics have been reported to decrease arterial responsiveness to pressor amines and to enhance the effect of tubocurarine. Caution should be exercised in administering curare or its derivatives to patients undergoing therapy with Furosemide Tablets and it is advisable to discontinue Furosemide Tablets for one day prior to any elective surgery.
FDA application 200-759
Furosemide Syrup 1% is a highly effective diuretic and, as with any diuretic, if given in excessive amounts may lead to excessive diuresis that could result in electrolyte imbalance, dehydration and reduction of plasma volume, enhancing the risk of circulatory collapse, thrombosis, and embolism. Therefore, the animal should be observed for early signs of fluid depletion with electrolyte imbalance, and corrective measures administered. Excessive loss of potassium in patients receiving digitalis or its glycosides may precipitate digitalis toxicity. Caution should be exercised in animals administered potassium-depleting steroids.
It is important to correct potassium deficiency with dietary supplementation. Caution should be exercised in prescribing enteric-coated potassium tablets.
There have been several reports in human literature, published and unpublished, concerning nonspecific small-bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric-coated thiazides with potassium salts. These lesions may occur with enteric-coated potassium tablets alone or when they are used with non-enteric-coated thiazides, or certain other oral diuretics. These smallbowel lesions may have caused obstruction, hemorrhage, and perforation. Surgery was frequently required, and deaths have occurred. Available information tends to implicate enteric-coated potassium salts, although lesions of this type also occur spontaneously. Therefore, coated potassium-containing formulations should be administered only when indicated, and should be discontinued immediately if abdominal pain, distension, nausea, vomiting, or gastrointestinal bleeding occurs. Human patients with known sulfonamide sensitivity may show allergic reactions to Furosemide Syrup 1%; however, these reactions have not been reported in animals.
Sulfonamide diuretics have been reported to decrease arterial responsiveness to pressor amines and to enhance the effect of tubocurarine. Caution should be exercised in administering curare or its derivatives to patients undergoing therapy with Furosemide Syrup 1% and it is advisable to discontinue Furosemide Syrup 1% for one day prior to any elective surgery. Keep Furosemide Syrup 1% in a secure location out of the reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.
Furosemide Syrup 1% Oral Syrup
Salix® is a highly effective diuretic and if given in excessive amounts as with any diuretic may lead to excessive diuresis which could result in electrolyte imbalance, dehydration and reduction of plasma volume enhancing the risk of circulatory collapse, thrombosis, and embolism. Therefore, the animal should be observed for early signs of fluid depletion with electrolyte imbalance, and corrective measures administered. Excessive loss of potassium in patients receiving digitalis or its glycosides may precipitate digitalis toxicity. Caution should be exercised in animals administered potassium-depleting steroids.
It is important to correct potassium deficiency with dietary supplementation. Caution should be exercised in prescribing enteric-coated potassium tablets.
There have been several reports in human literature, published and unpublished, concerning non-specific small-bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric-coated thiazides with potassium salts. These lesions may occur with enteric-coated potassium tablets alone or when they are used with nonenteric-coated thiazides, or certain other oral diuretics. These small-bowel lesions may have caused obstruction, hemorrhage, and perforation. Surgery was frequently required, and deaths have occurred. Available information tends to implicate enteric-coated potassium salts, although lesions of this type also occur spontaneously. Therefore, coated potassium-containing formulations should be administered only when indicated and should be discontinued immediately if abdominal pain, distention, nausea, vomiting, or gastro-intestinal bleeding occurs.
Human patients with known sulfonamide sensitivity may show allergic reactions to Salix®; however, these reactions have not been reported in animals.
Sulfonamide diuretics have been reported to decrease arterial responsiveness to pressor amines and to enhance the effect of tubocurarine. Caution should be exercised in administering curare or its derivatives to patients undergoing therapy with Salix® and it is advisable to discontinue Salix® for one day prior to any elective surgery.
SALIX® (furosemide injection)
Acute Toxicity:
The following table illustrates low acute toxicity of furosemide in three different species.
(Two values indicate two different studies.)
LD50 of furosemide in mg/kg body weight
SPECIES
ORAL
INTRAVENOUS
Mouse
1050-1500
308
Rat
2650-4600*
680
Dog
>1000 and >4640
>300 and >464
* NOTE: The lower value for the rat oral LD50 was obtained in a group of fasted animals; the higher figure is from a study performed in fed rats. Toxic doses lead to convulsions, ataxia, paralysis and collapse. Animals surviving toxic dosages may become dehydrated and depleted of electrolytes due to the massive diuresis and saluresis.
Chronic Toxicity
Chronic Toxicity studies with furosemide were done in a one-year study in rats and dogs. In a one-year study in rats, renal tubular degeneration occured with all doses higher than 50 mg/kg. A six-month study in dogs revealed calcification and scarring of the renal parenchyma at all doses above 10 mg/kg.
Reproductive Studies
Reproductive Studies were conducted in mice, rats and rabbits. Only in rabbits administered high doses (equivalent to 10 to 25 times the recommended average dose of 2 mg/kg for dogs and cats) of furosemide during the second trimester period did unexplained maternal deaths and abortions occur. The administration of furosemide is not recommended during the second trimester of pregnancy.
Contact Information
To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact ZyVet Animal Health Inc. at 1-877-779-9838. Additional information can be found at www.zyvetusa.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae
References on file in NADA 034-621
Furosemide Tablets 12.5 mg and 50 mg
Approved by FDA under ANADA # 200-759
Manufactured by:
Zydus Animal Health and Investments Limited, Ahmedabad, India
Distributed by:
ZyVet Animal Health Inc.
Pennington, NJ 08534
Rev.: 11/24
FDA application 200-759
Acute Toxicity:
The following table illustrates low acute toxicity of furosemide in three different species.
(Two values indicate two different studies.)
LD50 of furosemide in mg/kg body weight
SPECIES
ORAL
INTRAVENOUS
Mouse
1050-1500
308
Rat
2650-4600*
680
Dog
>1000 and >4640
>300 and >464
* NOTE: The lower value for the rat oral LD50 was obtained in a group of fasted animals; the higher figure is from a study performed in fed rats. Toxic doses lead to convulsions, ataxia, paralysis and collapse. Animals surviving toxic dosages may become dehydrated and depleted of electrolytes due to the massive diuresis and saluresis.
Chronic Toxicity
Chronic Toxicity studies with furosemide were done in a one-year study in rats and dogs. In a one-year study in rats, renal tubular degeneration occured with all doses higher than 50 mg/kg. A six-month study in dogs revealed calcification and scarring of the renal parenchyma at all doses above 10 mg/kg.
Reproductive Studies
Reproductive Studies were conducted in mice, rats and rabbits. Only in rabbits administered high doses (equivalent to 10 to 25 times the recommended average dose of 2 mg/kg for dogs and cats) of furosemide during the second trimester period did unexplained maternal deaths and abortions occur. The administration of furosemide is not recommended during the second trimester of pregnancy.
Contact Information
To report suspected adverse drug experiences, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Covetrus® North America at (855) 724-3461 or covetrus.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae
References on file in NADA 034-621
Furosemide Tablets 12.5 mg and 50 mg
Approved by FDA under ANADA # 200-759
Questions?
(855) 724-3461
Distributed by:
Covetrus® North America
400 Metro Place North
Dublin, OH 43017.
covetrus.com
Made in India
CC-FurosemideTabPI-01
REV: 0226
FDA application 200-759
Furosemide Injection is a highly effective diuretic and, if given in excessive amounts, as with any diuretic, may lead to excessive diuresis which could result in electrolyte imbalance, dehydration and reduction of plasma volume, enhancing the risk of circulatory collapse, thrombosis and embolism. Therefore, the animal should be observed for early signs of fluid depletion with electrolyte imbalance, and corrective measures administered. Excessive loss of potassium in patients receiving digitalis or its glycosides may precipitate digitalis toxicity.
Caution should be exercised in animals administered potassium-depleting steroids. Correct potassium deficiency with proper dietary supplementation. If animal needs potassium supplements, use oral liquid form; do not use enteric-coated potassium tablets.
The concurrent use of furosemide with some antibiotics may be inadvisable. There is evidence that the drug enhances the nephrotoxic potential of aminoglycosides, cephalosporins and polymyxins and increases the ototoxic effects of all aminoglycosides.
Sulfonamide diuretics have been reported to decrease arterial responsiveness to pressor amines and to enhance the effect of tubocurarine.
Caution should be exercised in administering curare or its derivatives to patients undergoing therapy with Furosemide Injection and it is advisable to discontinue Furosemide Injection for one day prior to any elective surgery.
Do not use in horses intended for human consumption.
Furosemide Injection 50 mg/mL
Furosemide tablets are a highly effective diuretic and, if given in excessive amounts, as with any diuretic, may lead to excessive diuresis which could result in electrolyte imbalance, dehydration and reduction of plasma volume, enhancing the risk of circulatory collapse, thrombosis and embolism. Therefore, the animal should be observed for early signs of fluid depletion with electrolyte imbalance, and corrective measures administered. Excessive loss of potassium in patients receiving digitalis or its glycosides may precipitate digitalis toxicity. Caution should be exercised in animals administered potassium-depleting steroids. Correct potassium deficiency with proper dietary supplementation. If animal needs potassium supplements, use oral liquid form, do not use enteric-coated potassium tablets.
The concurrent use of furosemide with some antibiotics may be inadvisable. There is evidence that the drug enhances the nephrotoxic potential of aminoglycosides, cephalosporins and polymyxins and increases the ototoxic effects of all aminoglycosides.
Sulfonamide diuretics have been reported to decrease arterial responsiveness to pressor amines and to enhance the effect of tubocurarine. Caution should be exercised in administering curare or its derivatives to patients undergoing therapy with Furosemide tablets and it is advisable to discontinue Furosemide tablets for one day prior to any elective surgery.
Furosemide Tablets